Product Compliance

On 1 September, GMP manufacturing becomes mandatory for Japan's tablet and capsule functional foods, and every label already on shelves must carry a new medicine-interaction warning: the reform follows a scandal whose own hotline logged 416 death reports, of which the manufacturer has confirmed zero

On 1 September 2026, Japan's two-year transition period following the Kobayashi beni koji supplement scandal ends: revised medicine-interaction labels become mandatory on every Foods with Function Claims product on shelves, and GMP manufacturing becomes mandatory for tablet and capsule products, even though the manufacturer has confirmed no case with a causal link among 416 death-related inquiries.

Naomie HaliouaCDO and co-founder 23 August 2026 · 6 min read

Two transition periods, one deadline

Japan's Foods with Function Claims system, launched in 2015, lets a business self-notify a product's function claim to the CAA using its own scientific evidence, without the pre-market government review required for Tokutei Hoken (FOSHU) health foods. That light-touch design is what made the March 2024 recall of Kobayashi Pharmaceutical's Beni Koji Choleste Help so damaging: a self-notified supplement, later found contaminated with puberulic acid from blue mould, was linked to kidney damage in users, over 240 hospitalisations by mid-April 2024, and a wave of reported deaths that Japan's health ministry (MHLW) never fully resolved. The government responded not by scrapping the self-notification model but by bolting two mandatory layers onto it: a revised Food Labeling Standard, effective 1 September 2024, and a revised GMP notification for supplement-form FFC products. Both carried a two-year transition period. Both end on 1 September 2026, for every product already on the market, not just new notifications filed after that date.

Three nuances that separate signal from noise

The headline death count and the confirmed death count are two different numbers

Kobayashi's own consultation line had logged 416 death-related inquiries by 5 January 2025, while Japan's health ministry separately tallied at least 113 deaths under investigation by August 2024. As of Kobayashi's own June 2026 update, the company states it has not identified a single case where death was clearly caused by the product.

GMP applies to the supplement-shaped subset, not to every FFC product

The mandate targets tablets, capsules and similar products made from concentrated natural extracts or chemically synthesised functional ingredients. A fresh food carrying a function claim, such as a specific fruit variety, sits outside the manufacturing-process rule entirely.

The label rule reaches backward, not just forward

The revised Food Labeling Standard took effect for new notifications on 1 September 2024. The two-year transition period that follows exists specifically so that products already notified and already selling get the same September 2026 deadline to update their packaging.

22 Mar 2024

Kobayashi Pharmaceutical recalls Beni Koji Choleste Help and related red yeast rice supplements after users report kidney problems; MHLW opens an investigation.

Apr 2024

Hospitalisations pass 240 by 18 April; MHLW later identifies puberulic acid, a blue-mould contaminant, as the cause of the kidney damage.

31 May 2024

The Japanese government publicly announces its plan to overhaul the Foods with Function Claims system.

Aug 2024

MHLW's under-investigation death tally reaches at least 113, after 11 previously unreported cases are added to an earlier count of 81.

1 Sep 2024

The revised Food Labeling Standard takes effect for new FFC notifications, with a two-year transition period for products already on the market.

5 Jan 2025

Kobayashi's own consultation line reaches 416 death-related inquiries; the company reiterates it has confirmed no causal link in any case.

1 Sep 2026

Both transition periods end: revised labels become mandatory on every FFC product on shelves, and GMP-based manufacturing becomes mandatory for supplement-form FFC products.

The numbers behind 1 September

One number is how large the FFC catalogue was before the scandal hit, the base the deadline now applies to. The other two are the same underlying case, counted two different ways by two different parties.

6,795

FFC products notified by 1,693 companies as of March 2024, the eve of the recall, all of which the September 2026 label deadline now reaches

113

deaths Japan's health ministry counted as under investigation for a possible link to the recalled supplements, as of August 2024

416 vs. 0

death-related inquiries logged by Kobayashi's own consultation line by January 2025, against the number of cases the company has confirmed as caused by the product, as of its most recent update

The real subject: a reform that does not wait for causation to be settled

Coverage of a product-safety scandal usually assumes the regulatory response follows from the final casualty count: once investigators establish how many people a contaminated product actually harmed, the rule gets calibrated to match. The FFC reform breaks that sequence. Japan's health ministry has never closed the gap between the 113 deaths it counted as under investigation in August 2024 and the 416 death-related inquiries Kobayashi's own hotline had logged five months later, and the company's own most recent statement still confirms zero cases with an established causal link. None of that ambiguity paused the reform. The CAA built the revised Food Labeling Standard and the GMP notification on a fixed two-year clock starting in September 2024, and that clock runs out on 1 September 2026 regardless of where the casualty count eventually settles. The system self-notification model, which let a business certify its own function claim without pre-market government review, is precisely why the fix had to be structural rather than case-by-case: with no government approval step to tighten, the only lever left was to mandate how the product is made and how its label reads, for every product already on the market, not to wait on a number.

Why it matters for brands

For any brand selling a supplement, vitamin or functional-food product into Japan under an FFC notification, whether manufactured domestically or imported, 1 September 2026 is a full-catalogue compliance sweep, not a formality for new launches. Every SKU already carrying a function claim needs its packaging checked against the revised standard: the boxed FFC mark and notification number in the right position, plus the specific medicine-interaction and overdose warnings tied to that product's own functional ingredient, since the wording is not generic across the category. Separately, any tablet, capsule or concentrated-extract product needs its manufacturing site checked against the GMP mandate, and for a foreign brand that means confirming, product by product, whether its existing GMP certification, domestic or from another market, is recognised as equivalent, rather than assuming it automatically qualifies. The two obligations run on the same clock but are decided by two different facts about a product, its label content and its physical form, which makes this a data-classification problem before it is a manufacturing or artwork problem: a brand needs a per-SKU record of function-claim wording, ingredient-specific warning text and manufacturing-site GMP status to know which of its Japan-market products are actually ready for 1 September, rather than finding out from a CAA corrective notice after the fact.

Two ways to read 1 September

The narrow read

A two-year transition period for Japanese supplement labels and manufacturing standards ends on schedule.

The structural read

Two years after a scandal whose casualty count was never resolved, one tally at 113, another at 416, none confirmed, the fix Japan actually deployed was structural: mandatory manufacturing standards and label content for an entire product category, applied without waiting for the underlying number to settle.

Frequently asked questions

What changes for Japan's Foods with Function Claims system on 1 September 2026?

Two transition periods created after the 2024 Kobayashi beni koji recall end on the same day. Every FFC product already on shelves must carry a revised label with a boxed FFC notice, its notification number, and ingredient-specific warnings on medicine interactions and excessive intake. Separately, GMP-based manufacturing becomes mandatory for FFC products sold as tablets, capsules or similar concentrated-ingredient formats.

What triggered Japan's functional food reform?

Kobayashi Pharmaceutical recalled its Beni Koji Choleste Help red yeast rice supplements in March 2024 after users reported kidney problems, later traced to contamination with puberulic acid from blue mould. Japan's health ministry counted at least 113 deaths under investigation for a possible link by August 2024, while Kobayashi's own consultation line logged 416 death-related inquiries by January 2025. As of the company's most recent update, it has not confirmed a causal link between the product and any death.

Which products need GMP manufacturing, and are foreign-made products exempt?

The GMP mandate applies to Foods with Function Claims sold as tablets, capsules or similar concentrated-ingredient formats made from natural extracts or synthesised functional ingredients, not to fresh foods carrying a function claim. Foreign-made products are not automatically exempt: a brand needs to confirm, product by product, whether its existing GMP certification is recognised as equivalent under the Japanese standard rather than assuming it qualifies.